Kornimate/medical-research-clean huggingface dataset:
extension study of idursulfase-it along with elaprase in children and adults with hunter syndrome and cognitive impairment

Conditions: Hunter Syndrome

Summary: the study is an extension of two previous studies (hgt-hit-046 \[nct01506141\] and shp609-302 \[nct02412787\]). participants must have completed one of the previous studies. the main aim of this study is to collect more information about the safety of the treatments, idursulfase-it and elaprase, in children and adults with hunter syndrome and cognitive impairment. participants will receive the same treatment as in the previous studies.

the drug being tested in this study is called idursulfase. idursulfase is being tested for long term safety in participants with hunter syndrome and cognitive impairment. the study will enroll up to approximately 8 patients. participants will receive idursulfase-it via intrathecal drug delivery device (iddd) once monthly along with elaprase intravenous (iv) infusion, weekly. this multi-center trial will be conducted in france and canada. the overall time to participate in this study is approximately 4.8 years.

Eligibility criteria:
inclusion criteria: 1. the participant must have completed end of study assessments in studies hgt-hit-046 \[nct01506141\] or shp609-302 \[nct02412787\] and received a clinical benefit from idursulfase-it in the opinion of the investigator. 2. the participant, or participant's legally designated representative, must have been informed of the nature of this open-label extension and must have voluntarily signed an institutional review board (irb)/independent ethics committee (iec) approved informed consent form after all relevant aspects of the study have been explained and discussed. written consent of the participant's legally designated representative (if applicable) and the participant's consent/assent, as relevant, must be obtained. 3. the participant has continued to receive elaprase on a regular basis in studies hgt-hit-046 or shp609-302. exclusion criteria: 1. the participant has experienced, in the opinion of the investigator, a safety or medical issue that contraindicates treatment with idursulfase-it, including, but not limited to, uncontrolled seizure disorder, bleeding disorder, and clinically relevant hypertension. 2. the participant has clinically relevant intracranial hypertension. 3. the participant is enrolled in another clinical study, other than studies hgt-hit-046 or shp609-302, that involves clinical investigations or use of any investigational product (drug or \[intrathecal/spinal\] device) within 30 days prior to study enrolment or at any time during the study.

Keywords: drug therapy
a single-arm study evaluating the effectiveness and safety of suzetrigine (suz) for acute pain after selected surgeries

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the effectiveness, safety, and tolerability of suz for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.


Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of greater than or equal to (≥) 18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2) * scheduled to undergo a procedure that is in one of the following categories that would typically be treated with opioid therapy for at least 72 hours postoperatively such as * laparoscopic intraperitoneal or retroperitoneal procedure * arthroscopic orthopedic procedure key exclusion criteria: -participated in previous study with suzetrigine or received journavx other protocol defined inclusion/exclusion criteria will apply.
effects of antidepressants on sexual functioning

Conditions: Major Depressive Disorder (MDD)

Summary: the purpose of this trial is to study the effects of two depression medications on sexual functioning.


Eligibility criteria:
inclusion criteria: * primary diagnosis of major depressive disorder (mdd) with current duration lasting 12 weeks but no greater than 2 years. * subjects must engage in sexual activity that leads to orgasm at least once every two weeks. * subject must have normal orgasmic function and be willing to discuss with investigator. exclusion criteria: * subjects that have arousal or orgasm dysfunction. * has previously failed to respond to two adequate trials of antidepressants in past 2 years. * subject has other unstable medical disorders. * subject has a positive urine test for illicit drug use at screening.

Keywords: depression mdd sexual dysfunction orgasm disorder
target site pharmacokinetics of doripenem at steady state in intubated intensive care patients

Conditions: Pneumonia; Abdominal Infection; Urinary Tract Infection

Summary: the investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.

methods: microdialysis, blood sampling, bronchoalveolar lavage

Eligibility criteria:
inclusion criteria: * endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection exclusion criteria: * allergy to doripenem, hemodialysis

Keywords: intensive care patient intubation (please change wording as you like!)
lenvatinib, tislelizumab plus gemcitabine and cisplatin (gplet) in patients with advanced cholangiocarcinoma

Conditions: Advanced Cholangiocarcinoma

Summary: cholangiocarcinoma (cca) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery. as more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced cca. cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of t cells. tyrosine kinase inhibitors (tki) can reduce the expression of pd-l1 and inhibit treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment. therefore,we aim to investigate the safety and efficacy of lenvatinib, tislelizumab combined with gemcitabine plus cisplatin (gplet) in the treatment of advanced cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients. * the world health organization (who)/ecog physical state (ps) to 0 or 1. * at least 1 recist 1.1 standard target lesions. * not previously received immunotherapy, including but not limited to ctla 4, pd-l1 or/and pd-1 inhibitors. * adequate organ and bone marrow function, defined as follows: 9.0 g/dl or higher hemoglobin; neutrophil count 1.5 x 109 / l; platelet count 100 x 109 / l. exclusion criteria: * active or previously documented autoimmune disease or inflammatory disease. * uncontrolled complications. * history of other primary malignancies. * active infection. * women who are pregnant or breastfeeding.

Keywords: lenvatinib; gemcitabine and cisplatin; tislelizumab; cholangiocarcinoma
trial of perioperative chemotherapy (gemcitabine and cisplatin) and adjuvant chemoradiotherapy (with weekly low dose gemcitabine) in patients with lung cancer with positive nodes

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to test feasibility, toxicity and efficacy of two different adjuvant treatment schedules in stage ii-iiia non-small cell lung cancer patients with positive lymph nodes.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of nsclc (any subtype). for patients entering arm b is also allowed to confirm histopathological diagnosis of nsclc intraoperatively during this trial. * node positive (clinically or pathologically) stage ii disease or stage iiia: t1n1 or t2n1 or t1n2 or t2n2 or t3n1 or t3 n2, according to the revision by mountain cf of american joint committee on cancer (mountain cf 1997, fleming id et al. 1997). for patient entering arm b (with n0 stage) confirmation of n1-n2 stage must be obtained from intraoperative or post-surgery pathology report. * tumor amenable to curative surgical resection. * patients with clinically measurable lesions will be enrolled in this study. measurability is determined according to recist criteria. • pathological evaluation is performed after mediastinoscopy or after surgery * no prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, or any other type of tumor therapy). exclusion criteria: * treatment within the last 30 days with any investigational drug. * concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy. * serious concomitant disorders (for example, heart failure, poorly controlled diabetes) at the investigator's discretion. * presence of an uncontrolled, active infection requiring therapy (at the discretion of investigator.). * stage iiib or iv.
'activity pacing' in plwh with fatigue symptoms.

Conditions: Hiv

Summary: physical activity helps to improve health and prevent chronic diseases. however, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (cfcs), such as persons living with hiv (plwh). we hypothesize that the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of plwh with fatigue symptoms. motivation and adherence to exercise will be monitored through the use of digital supports.


Eligibility criteria:
inclusion criteria: * of age ≥18 years; * either sedentary or already practicing mild/moderate physical activity (at least 150 minutes of moderate-intensity physical activity throughout the week); * able to sign the informed consent. exclusion criteria: the study will exclude hiv+ individuals: * with any hiv-related disease requiring hospitalization in the 6 weeks before enrolment; * with medical conditions (e.g. neurologic, muscular-skeletal, cardiovascular diseases) contraindicating non agonistic exercise, as established by a sport medicine specialist; * currently abusing of substance or alcohol; * already performing physical activity at higher level than the current who recommendations (30 minutes of moderate activity 5 times a week).
effects of attention training on children

Conditions: Attention Deficit Hyperactivity Disorder

Summary: using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with attention deficit hyperactivity disorder who are receiving conventional rehabilitation programs due to developmental delay.

a total of 30 children with attention deficit hyperactivity disorder conducting conventional rehabilitation programs well be enrolled. the children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training. therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention. the evaluator and children will be blinded to the group's allocation during the whole course of the intervention.

Eligibility criteria:
inclusion criteria: * children with a diagnosis of attention deficit hyperactivity disorder with developmental delay, under regular conventional rehabilitation programs, intelligence quotient 70 or greater exclusion criteria: * age less than 4 or greater than 8 of children diagnosed with attention deficit hyperactivity disorder with developmental delay, under regular conventional rehabilitation programs, intelligence quotient less than 70

Keywords: attention training children therapeutic effects developmental delay
promoting adherence to sleep apnea treatment among blacks with metabolic syndrome

Conditions: Obstructive Sleep Apnea

Summary: this is a randomized controlled trial to evaluate effect of a culturally and linguistically tailored, telephone-delivered behavioral intervention on adherence to recommended assessment and treatment of sleep apnea in blacks with metabolic syndrome. the investigators believe low awareness of sleep apnea and the risk it imposes to an individual health plays an important role in underdiagnosis and low adherence to treatment among blacks. hence, culturally and linguistically tailored health education will decrease the knowledge gap and improve adherence to recommended assessment and treatment of sleep apnea. the investigators believe the effect of adherence to treatment of sleep apnea is shown to improve the components of metabolic syndrome and hence promote well control of hypertension, diabetes, weight, triglyceride and cholesterol.

primary aim: to evaluate effect of a culturally and linguistically tailored, telephone-delivered behavioral intervention, versus an attention-control condition, on adherence to recommended assessment and treatment of sleep apnea. secondary aims: 1) to evaluate the maintenance of intervention effects on adherence 6 months post-intervention; and 2) to assess treatment effects on components of the metabolic syndrome (waist circumference, blood pressure, lipid level, and fasting plasma glucose/hba1c). exploratory aim: to identify the mediators of adherence to recommended sleep apnea assessment and treatment following exposure to the intervention.

Eligibility criteria:
inclusion criteria: * age \> 18 years * african american / carribean american / african. exclusion criteria: * pregnancy or breastfeeding * involvement with other study * unable to understand and sign the informed consent form * heart attack or stroke within the past 12 weeks * diagnosed with obstructive sleep apnea and/or on treatment

Keywords: tailored telephone intervention
efficacy of nano-ivermectin impregnated masks in prevention of covid-19 among healthy contacts and medical staff

Conditions: Covid-19

Summary: antiviral efficacy of ivermectin against covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano ivermectin solution will theoretically increase the protective action of the ordinary masks

antiviral effecacy of ivermectin against covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano ivermectin solution will theoretically increase the protective action of the ordinary masks this study is a trial for evaluation of adding a proved antiviral material to the mask and to compare between the protective value of this mask and the ordinary one.

Eligibility criteria:
inclusion criteria: * health care personells and family contact of confirmed covid-19 cases. exclusion criteria: * refusal of participate to use the masks. * pregnancy or lactation known hypersensitivity to ivermectin.

Keywords: covid-19 antiviral mask nano ivermectin
hiit with an eccentric hamstring exercise program in futsal players

Conditions: Athletic Injuries

Summary: physiotherapy protocols based on high-intensity interval training (hiit) or eccentric hamstring exercises like nordic curl (nc) have been scarcely studied in futsal players. the hypothesis of this study is that a hiit combined with an nc exercise program is more effective than a hiit-only program in improving physical and functional characteristics in futsal players.

the objective of this study was to compare the effectiveness of a hiit combined with an nc exercise program versus a hiit-only program in futsal players. therefore, a randomized controlled trial will be carried out. futsal players will be divided into 1) hiit+nc group and 2) hiit group. the hiit+nc group will perform a hiit circuit combined with 3 sets of 10 nc repetitions for 4 weeks, while the hiit group will perform the same protocol without nc exercise. bmi, intermittent work performance, vertical jump performance without and with arms, isometric strength of quadriceps and hamstrings, and the isometric h/q ratio, will be assessed before and after the interventions.

Eligibility criteria:
inclusion criteria: * futsal players, over 18 years of age. exclusion criteria: * those who had a medical condition that prevented them from performing any of the evaluations. * those who declined to participate
study to evaluate pregnancy outcomes in risankizumab exposed pregnancies relative to those non-risankizumab exposed pregnancies in women with fda approved indications

Conditions: Plaque Psoriasis; Psoriatic Arthritis; Crohn Disease; Other Conditions for Which Risankizumab is an FDA-approved Treatment

Summary: the objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (psa), crohn's disease (cd), or other conditions for which risankizumab is an fda-approved treatment. the registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations. approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the united states. participants will not receive risankizumab as part of this study. maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery there may be a higher burden for participants in this study compared to standard of care. participants will attend visits determined by hcps during the study at a hospital or clinic. the pregnancy outcomes including side effects will be collected during routine clinical care.


Eligibility criteria:
inclusion criteria: risankizumab-exposed cohort * us resident. * current pregnancy. * diagnosis of plaque psoriasis, psa, cd, or other condition(s) for which risankizumab is an fda-approved treatment while the study is recruiting. * exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception). diseased comparison cohort * us resident. * current pregnancy. * diagnosis of plaque psoriasis, psa, cd, or other condition(s) for which risankizumab is an fda-approved treatment while the study is recruiting. * exposure to other medications in the same class or line of therapy as risankizumab (tnf inhibitors, il-17 inhibitors, il-12/23 inhibitor, and other il-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life). exclusion criteria: risankizumab-exposed cohort * exposure to other medications in the same class or line of therapy as risankizumab (tnf inhibitors, il-17 inhibitors, il-12/23 inhibitor, and other il-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life). * occurrence of pregnancy outcome prior to enrollment in the registry diseased comparison cohort * exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception). * occurrence of pregnancy outcome prior to enrollment in the registry

Keywords: pregnancy risankizumab skyrizi™ risankizumab-rzaa
a study of pegasys (peginterferon alfa 2a) alone or in combination with tenofovir in patients with chronic hepatitis d.

Conditions: Hepatitis D, Chronic

Summary: this randomized, single blind study will compare the antiviral effect of pegasys (pegylated interferon alfa-2a) plus placebo versus pegasys plus tenofovir in patients with chronic hepatitis d. patients will be randomized to receive 96 weeks of therapy with pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). anticipated time on study treatment is 2+ years, target sample size is \<50.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * chronic hepatitis d * positive for hbsag \>/=6 months, for anti-hdv \>/=3 months and for hdv-rna at screening * negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study exclusion criteria: * antiviral therapy for chronic hepatitis d within the previous 6 months * previous therapy with pegylated interferon alfa * treatment with conventional interferon alfa for \>12 months * hepatitis a or c, or hiv infection * decompensated liver disease (childs b-c) * history or evidence of medical condition associated with chronic liver disease
treatment and prevention of progression of interstitial lung disease in systemic sclerosis

Conditions: Systemic Sclerosis; Interstitial Lung Diseases

Summary: systemic sclerosis (ssc) is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis. this observational trial (ot) is part of the collaborative project "desscipher", one out of five ots to decipher the optimal management of systemic sclerosis. aim of this observational try is to identify: * the state of clinical practice in europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression * the potential predictors and confounders for response to therapy

patients are routinely evaluated every 3 months over a 12-months period by medical history, physical examination, pulmonary function tests, vas lung score and sf-36, shaq. also, their medication and possible medication changes will be recorded.

Eligibility criteria:
inclusion criteria: * diagnosis fo ssc according to the acr/eular criteria for adult or the pres/acr/eular criteria for juvenile ssc patients * ssc patients with proven ild (by x-ray or ct scan) * treatment with standard dosages according to current practice with (i) cyclophosphamide, (ii) azathioprine, (iii) mycophenolate mofetil, (iv) methotrexate, or (v) no therapy exclusion criterion: * patients with previous exposure to silica or asbestos